Skip to content

Diagnostix™ 543122L

by American Diagnostic Corporation

Diagnostix 543122L is an ophthalmic/otologic diagnostic set (FDA Class I; FDA product code ERA, Otoscope) made by American Diagnostic Corporation, cleared under FDA 510(k) K932506 on 8 Oct 1993, registered in EUDAMED and listed in FDA GUDID since 27 Dec 2023 (UDI-DI 00634782100537), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K932506

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00634782100537 UDI-DI Date27 Dec 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK932506 Date8 Oct 1993DecidedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K932506 decided 8 Oct 1993 Active
  • EUDAMED Active· +1 more in the status table
  • FDA GUDID UDI-DI 00634782100537 listed 27 Dec 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K932506
  2. Listed FDA GUDID 00634782100537

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Diagnostix™
Generic name
Ophthalmic/otologic diagnostic set
Model / Ref / Catalog
543122L
Primary DI / UDI-DI
00634782100537
510(k) Number
FDA product code
ERA
GMDN term
Ophthalmic/otologic diagnostic set
Device class
Class I
Regulation number
874.4770
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ophthalmic/otologic diagnostic set

Cleared under the same submission (K932506)

and 8 more cleared under K932506

Similar devices

Other devices filed under FDA product code ERA (Otoscope).

Other devices from American Diagnostic Corporation

See all devices from American Diagnostic Corporation →

Properties

  • Over-the-counter
  • Convenience kit
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)